A rating system, for ultraviolet A (UVA) protection in sunscreens is finally on the horizon. For the first time since 1999, the U.S. Food and Drug Administration (FDA) has proposed new sunscreen rules, which would include the first U.S. standards for UVA testing and labeling; the rules would also cap SPF numbers at 50+ and ban certain terms in labeling.

Physicians and consumers have long awaited FDA standards for UVA protection, since UVB protection alone does not provide adequate sun defense. To date, a sunscreen’s effectiveness in the U.S. is measured solely by SPF, or Sun Protection Factor. SPF numbers indicate how long it will take for UVB rays to redden your skin when you use a sun protection product, compared to how long the skin would take to redden without the product. The higher the SPF, the longer skin can be sun-exposed before burning. However, UVA rays damage the skin without burning, and SPF measurements apply only to UVB protection.

The Truth Emerges

UVB rays, short-wave radiation with wavelengths of 290-320 nanometers, were long considered the main wavelengths behind skin cancer. However, recent research has shown that UVA, long-wave radiation of 320-400 nanometers, is the predominant cause of premature skin aging, and also a significant cause of skin cancer. UVA invades the skin more deeply than UVB, perhaps producing more damage than UVB.

Many sunscreens in the U.S. today provide significant UVA defense; usually boasting of “broad spectrum” or “UVA/UVB” protection, they contain ingredients such as zinc oxide, titanium dioxide, avobenzone, or, since last year, Mexoryl. But standardized UVA testing and labeling are used only outside the U.S., particularly in Europe. Here, the FDA has had no criteria for determining or labeling a sunscreen’s level of UVA protection.

Until now. The proposed regulations would use a 1-4 star rating system to gauge UVA protection, with 1 star the lowest and 4 the highest. Products without a star would be marked “No UVA protection.”

The FDA rating would be based on two tests: the first, conducted in a lab (in vitro testing), would use a sun simulator to measure the “product’s ability to reduce the amount of UVA radiation that passes through it.” It would include a measurement for “photostability” – the sunscreen’s ability to maintain effectiveness for some hours without being degraded by the sun. The second test, similar to the SPF test, would assess the sunscreen’s ability to prevent tanning or reddening on a person (in vivo testing). According to Rita Chappelle of the FDA, if the two ratings vary, “the lower one would apply.”

SCF Backing

“Consumers can get a full picture of the protection sunscreen offers only if a UVA protection measurement is added,” declared Skin Cancer Foundation President Perry Robins, MD. “The FDA proposal will accomplish this.”

In fact, the Foundation plans to start requiring all sunscreen companies applying for its Seal of Recommendation to demonstrate adequate UVA protection.

Time To Reflect

Health organizations, manufacturers, and healthcare professionals have three months to respond to the proposals. After this comment period, which ends November 26, 2007, the FDA plans to adapt the rules as soon as possible. However, it could take two years or more before the rules are implemented. Sunscreen manufacturers will then have one year to comply.

In the meantime, looking for The Skin Cancer Foundation’s Seal of Recommendation on sunscreen labels – along with checking the labels for one or more UVA-protective ingredients – is a good way to ensure you’re properly protected.

Further Proposals

The FDA proposals also recommended these key changes in sunscreen labeling:

• Sunscreen packaging must include a warning that sunscreen is just one part of a comprehensive sun protection program, along with instructions to reapply every two hours, limit sun exposure, and wear protective clothing.
• 50+ would be the highest SPF manufacturers could claim. In 1999, the FDA proposed limiting SPFs to 30+, but The Skin Cancer Foundation and other groups argued that this number was too low. An SPF of 15 filters out 93 percent of UVB, SPF 30 filters out 97 percent and SPF 50 98 percent; these differences can be significant for people who are prone to skin cancer or sun damage, who have a suppressed immune system, or who are taking medication that causes photosensitivity. Numbers above 50, however, offer negligible increases in protection. “The 50+ SPF cap will ensure adequately protective sunscreen products, while avoiding a needless SPF ‘race to the top’ by manufacturers,” notes Warwick L. Morison, MD, chairman of the Foundation’s Photobiology Committee.
• The term “Sun Protection Factor” would become “Sunburn Protection Factor,” since SPF represents protection only against UVB, the sunburning rays.
• The terms “waterproof” and “sunblock” would be disallowed to avoid misleading consumers. No sunscreen is entirely impervious to water or able to “block” the sun’s rays fully. Products that retain their SPFs after 40 or 80 minutes’ immersion in water would be labeled “water resistant” or “very water resistant,” respectively. “The changes in the labeling requirements,”

Dr. Morison notes, “will greatly improve consumer education about sunscreen use.”